Strata® 44420 (UDI 00763000027537)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000027537), received between Jul 20, 2023 and Apr 9, 2026 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Mechanical Jam” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K123524); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE LUMBOPERITONEAL VALVE WAS IMPLANTED ON (B)(6) 2024, AND AFTER ALMOST 2 YEARS, THE DEVICE SEEMED TO HAVE A MALFUNCTION AS THE HEALTHCARE PROFESSIONAL COULD NOT CHANGE THE PROGRAM LEVEL. 3 DIFFERENT PROGRAMMERS WERE TRIED AND CHECK WITH X-RAYS. THE DEVICE WAS TO BE REPLACED IN THE NEXT WEEKS. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24831218 ↗
• InjuryJan 26, 2026Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE PATIENT'S SHUNT WAS PLACED ON THE (B)(6) 2026. THE PATIENT WAS DOING BETTER, AND THE DOCTOR REPORTED NO ISSUE AT THE TIME OF IMPLANT. THE DOCTOR STATED THAT THEY DID NOT PUMP THE VALVE OR TRY WITHDRAWAL CEREBROSPINAL FLUID (CSF) THROUGH THE VALVE WITH A SYRINGE. THE DOCTOR SAID THE PATIENT'S PRESSURE WAS HIGH, AND SO THE SHUNT FILLED EASILY, AND CSF WAS FLOWING OUT THROUGH THE CATHETER BEFORE THEY CLOSED. THE ISSUE CAME ON WHEN THE DOCTOR WANTED TO ADJUST THE SHUNT FROM 2 TO 2.5, AND THE SHUNT SETTING WOULD NOT MOVE. THE DOCTOR TRIED MULTIPLE TIMES TO ADJUST THE SHUNT, EVEN WITH DIFFERENT PROGRAMMERS. THEY TRIED TAKING THE SHUNT SETTINGS BACK DOWN FROM 2 TO 1, TO TRY SEE IF IT WOULD GO THE OTHER WAY, BUT THEY COULD NOT GET IT TO MOVE IN EITHER DIRECTION. THEY EVEN TRIED WITH THE OLD MAGNETIC PROGRAMMER TO SEE IF THAT WOULD WORK. THE VALVE WAS REPLACED. THE PATIENT'S PREVIOUS MEDICAL HISTORY WAS HIGH PRESSURE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24178164 ↗
• MalfunctionDec 9, 2025Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT WAS DIAGNOSED WITH IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS AND REQUIRED A SUBARACHNOID-PERITONEAL SHUNT PROCEDURE. INTRAOPERATIVELY, VALVE LEAKAGE WAS IDENTIFIED, AND THE DEVICE WAS SUBSEQUENTLY REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23755874 ↗
• InjuryDec 3, 2025Mechanical Jam; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE SHUNT. IT WAS REPORTED THAT THE DOCTOR HAD AN ISSUE WITH PROGRAMMING THE SHUNT THAT WAS IMPLANTED ON (B)(6) 2025. THE SHUNT WAS JUMPING FROM 1.5 MM H2O TO 2 MM H2O. THE DOCTOR WAS UNABLE TO REPROGRAM TO A CONSTANT 1.5 MM H2O. THE PATIENT'S CONDITION WAS DETERIORATING AS THEY WERE EXPERIENCING EYE SIGHT DISTURBANCES, NAUSEA, FEELING OF UNWELL, AND HEADACHES. THE DOCTOR SUSPECTED THE SHUNT WAS COMPROMISED OR FAULTY. THE PATIENT WAS TAKEN BACK TO THEATRE TO EXPLANT AND REPLACE THE SHUNT. THE DOCTOR REPLACED THE VALVE AND LUMBAR CATHETER, BUT THE PERITONEAL CATHETER REMAINED IMPLANTED. THE PATIENT'S MEDICAL HISTORY INDICATED AN ALLERGY TO PENICILLIN. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Headache; Malaise; Nausea; Visual Disturbances

  MAUDE report 23703834 ↗
• MalfunctionDec 10, 2024Infusion or Flow Problem; Infusion or Flow Problem

  ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SHUNT FAILED ON (B)(6) 2024.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Pain; Vertigo

  MAUDE report 20893443 ↗
• InjuryNov 21, 2024Break; Fracture; Infusion or Flow Problem; Break; Fracture; Infusion or Flow Problem

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THE LUMBOPERITONEAL SHUNT WAS PLACED ON (B)(6) 2024. THE NOTES FROM THE IMPLANT STATED THAT THE PERITONEAL CATHETER WAS NOT PATENT AFTER TUNNELING TO THE ABDOMEN WOUND (NO FREE FLOW CEREBROSPINAL FLUID SEEN). THERE WAS NO KINKING SEEN. THE ABDOMEN CATHETER WAS DISCONNECTED FROM THE SHUNT AND WAS FOUND THAT ALL PROXIMAL PARTS WERE PATENT. THE ABDOMEN CATHETER WAS REMOVED FROM THE PATIENT AND WAS REPLACED WITH A BACTISEAL CATHETER FROM ANOTHER MANUFACTURER. THE PATIENT THEN EXPERIENCED A SUDDEN RECURRENCE OF HEADACHES RECENTLY WITH NO HISTORY OF INJURY OR CONTACT SPORT. X-RAY AND CT SCAN FOUND THAT THE LUMBAR CATHETER HAD FRACTURED AT THE L3/4 INSIDE THE INTERSPINOUS SPACE. THE DAMAGED SHUNT WAS REPLACED AND REPLACED WITH A NEW SET ON (B)(6) 2024. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: Headache

  MAUDE report 20744713 ↗
• MalfunctionNov 5, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT ON (B)(6) 2024, THE PATIENT WAS DIAGNOSED WITH IDIOPATHIC NORMAL PRESSURE HYDROCEPHALUS AND REQUIRED A SUBARACHNOID-PERITONEAL SHUNT. DURING THE OPERATION, THE VALVE WAS FOUND TO BE LEAKING. THE VALVE WAS REPLACED WITH A NEW ONE. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610008 ↗
• MalfunctionJul 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  MEDTRONIC RECEIVED INFORMATION REGARDING AN ADJUSTABLE VALVE. IT WAS REPORTED THAT AFTER OPENING, THE DEVICE LEAKED AS SOON AS IT WAS USED. THE DEVICE WAS REPLACED WITH A BACKUP PRODUCT. THE PATIENT'S STATUS WAS ALIVE-NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19760200 ↗
• MalfunctionSep 18, 2023Complete Blockage; Insufficient Device Problem Information; Complete Blockage; Insufficient Device Problem Information

  MEDTRONIC RECEIVED INFORMATION REGARDING A SHUNT. IT WAS REPORTED THAT THE PATIENT'S SHUNT WAS NOT WORKING. THE REPORTER WAS NOT ABLE TO PROVIDE ANY ADDITIONAL DETAILS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17765095 ↗
• MalfunctionJul 20, 2023Infusion or Flow Problem; Mechanical Jam; Infusion or Flow Problem; Mechanical Jam

  MEDTRONIC RECEIVED INFORMATION REGARDING A STRATA SHUNT. IT WAS REPORTED THAT THE VALVE PRESSURE WAS ADJUSTED BEFORE THE SURGERY, BUT IT COULD NOT BE ADJUSTED TO THE TARGET GEAR. THE PROCEDURE WAS COMPLETED WITH BACKUP PRODUCT. NO PATIENT PRESENT AT THE TIME OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361735 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K123524. One submission often covers many models, so check the product and lot details in each record.

• Z-1116-2021 · Jan 11, 2021 · Open, Classified
  Medtronic Cerebro Spinal Fluid Flow Control Valves and Shunts. STRATA II Valves and Shunts for the following CFNs: 27739 - SHUNT 27739 STRATA NSC SNAP SML 120CM, 27740 - SHU